About Us

• We operate at the forefront of pharmaceutical/biological manufacturing, with a mission to deliver safe, effective products at scale.
• Our Drug Product Finished Goods (DPFG) organization thrives on collaboration, operational excellence, and resilience—partnering across manufacturing, quality, and support teams to meet critical timelines without compromising quality.
• You’ll report to the Senior Director, DPFG, lead a growing team (approximately 4–8 direct reports), and work cross-functionally with leaders across Manufacturing Support, Quality, and Operations.

Responsibilities During the project phase

• Lead, manage, and build the investigations team, including hiring, onboarding, and capability development.
• Ensure the team is trained on investigational and root-cause tools to be fully ready for GMP operations.
• Transfer and stand up the deviation management process from a sister site while building out the function locally.
• Administer company policies that directly impact employees.
• Complete administrative tasks (e.g., timecard approvals, time-off approvals, expense reports).
• Perform other duties, as assigned.

In operations

• Manage, lead, develop, and mentor a team of investigators; organize and coordinate daily/weekly workloads and priorities.
• Ensure on-time closure of investigations while maintaining high-quality, data-driven investigation standards.
• Serve as the primary manufacturing contact for customers on investigation management, specific investigations, and status updates.
• Drive continuous improvement by holding the team accountable for creating effective CAPAs and validating CAPA effectiveness.
• Partner cross-functionally with Manufacturing Support leaders to identify, train, and maintain an auxiliary pool of competent investigators to ensure on-time, high-quality closures.
• Track and report resilience and manufacturing support compliance metrics and KPIs, including on-time CAPA closures and effectiveness checks.
• Act as investigations lead during regulatory inspections and audits; effectively communicate results and recommendations.
• Foster an inclusive, people-first culture through meaningful development plans, regular 1:1s, and skip-level 1:1s on a defined cadence.
• Complete administrative tasks (e.g., timecard approvals, time-off approvals, expense reports).
• Perform other duties, as assigned.

Minimum Qualifications

• Education and experience (one of the following):
  • High school diploma or GED with 10 years in life sciences, pharmaceuticals, or regulated industries; or
  • Bachelor’s degree with 6 years in life sciences, pharmaceuticals, or regulated industries; or
  • Master’s degree with 4 years in life sciences, pharmaceuticals, or regulated industries.
• Prior experience managing, leading, and developing people.
• Experience with regulatory inspections, investigations, and change management.
• Knowledge and experience with root cause analysis tools.
• 2–3 years of experience leading investigations or an investigations team.

Preferred Qualifications

• 6–10 years’ experience in pharmaceutical/biological manufacturing operations.
• Previous experience leading others in a pharmaceutical/biological manufacturing facility.
• Experience working in a changing, project-driven organization.
• Lean certification or similar continuous improvement certification.

Knowledge, Skills, and Abilities

• Strong collaboration skills across manufacturing and cross-functional teams.
• Excellent organizational and project management capabilities; able to prioritize and deliver under tight timelines.
• Champion for continuous improvement with a track record of driving effective CAPAs.
• Advanced understanding of GMP, inspection requirements, safety, and manufacturing operations.
• Proven ability to coach, lead, and develop individual contributors.

Benefits

• Comprehensive healthcare coverage (medical, dental, vision) for you and eligible dependents.
• Retirement savings plan with company match.
• Paid time off, company holidays, and paid parental leave.
• Employee well-being resources, including mental health and family support programs.
• Professional development opportunities, mentorship, and access to training/certifications.
• Inclusive, people-first culture with clear growth pathways and performance feedback.
• Flexible work practices where role-appropriate and business needs allow.

Inclusion Statement

• We value diverse perspectives and experiences. If you meet the minimum qualifications and are excited by this role’s purpose, we encourage you to apply—even if your experience doesn’t align with every preferred qualification. Accommodations are available upon request during the recruitment process.